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NCT Number: NCT05311371

The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients

Nausea and vomiting are serious problems in patients undergoing autologous stem cell transplantation. It is stated that the incidence of acute and delayed nausea and vomiting is more than 50%, even if the patient has been given antiemetic prophylaxis during the treatment process.

Breathing is the easiest relaxation exercise applied during the flow in everyday life and also one of the most important and essential parts of other relaxation exercise. The handbooks prepared for the patients undergoing chemotherapy recommend deep breathing exercises in order to prevent their nausea and vomiting.

The aim of this study is to determine the effect of respiratory exercise on chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell transplantation.

Research Hypotheses Ho: Respiratory exercise is not effective in preventing chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant patients.

H1: Respiratory exercise is effective in preventing chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant patients.

In the literature, no study has been found investigating the effect of breathing exercises on chemotherapy-induced nausea and vomiting for autologous hematopoietic stem cell transplantation patients.

The aim of this study is to determine the effect of respiratory exercise on chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell transplantation.

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University Hospital

Istanbul, 34025, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Least 18-years-old,
  • Autologous hematopoietic stem cell transplantation and take high-dose chemotherapy,
  • not have any communicative problems,
  • not have Coronavirus disease (COVID-19) disease or respiratory disease,
  • Hb value of 10 and above and
  • knowing how to read, write, and speak Turkish

Exclusion criteria

  • have respiratory disease and Coronavirus disease (COVID-19),
  • having any communication and psychiatric problem,
  • not knowing how to read, write, and speak Turkish,
  • not wanting to participate in the study and have anemia.

Treatment and study plan

Breathing Exercise Group

Other

The exercise was applied in accordance with the "Guideline on Breathing Exercise for Reducing Nausea and Vomiting" prepared by the researcher in accordance with the literature. In addition, the researcher has a breath coaching certificate. The guideline include the application steps of breathing exercise. First, the researcher will demonstrate to the patients the practice of breathing exercise in accordance with the guideline. In the next step, patients they will be asked to do this application on themselves. The training is planned to take about 15-20 minutes for each patient. This guide will be given to patients after the training. They will be asked to do this breathing exercise correctly and effectively in accordance with the guideline for at least 5 min in case of sensation of nausea and vomiting for 14 days. The researcher will follow up the patients for 14 days by visiting room them every day.

Control Group

Other

No intervention

Primary outcomes

  1. Patient Information Form

    Time frame: Baseline

    Patient Information Form is a form prepared to determine the sociodemographic and disease-related characteristics of the patients. Sociodemographic characteristics of patient are composed of height, age, weight, educational status, social security, occupation, marital status, nutritional habits, smoking and alcohol use. Patient Information Form have general information about the patients such as diagnosis, duration, stage, and metastasis status of the disease, antiemetic drugs and treatment history. Disease history of cancer is , nausea-vomiting complaints before chemotherapy, the presence of any non-pharmacological method used to reduce nausea and vomiting induced by chemotherapy drugs.

Secondary outcomes

  1. Rhodes Index of Nausea, Vomiting ve Retching

    Time frame: Baseline and 14 days

    Responses to each item are classified by using expressions appropriate to the item and scoring the severity of the nausea-vomiting-retching experience from 0 to 4. There are eight items in this scale that evaluate the experience, frequency and distress of nausea-vomiting and retching. The increase in score reflects worsening of the complaint experienced.

Other outcomes

  1. Daily Nutritional Consumption Amount Form

    Time frame: Baseline and 14 days

    The amount of consumption of the patient in the morning, lunch, evening and snacks will be recorded before the treatment and throughout the study. The patient's antiemetic treatment, enteral and parenteral nutrition will be recorded daily in the follow-up form.

  2. Patient Nausea And Vomiting Episode Follow-Up Form

    Time frame: Baseline and 14 days

    This follow-up chart was created by the researcher in order to evaluate the severity and episode of nausea and vomiting symptom during chemotherapy treatment and post-transplantation in patients with autologous hematopoietic stem cell transplantation. The scale consists of a 100 mm/10 cm long horizontal line. On the left end of the line, there is 0 "No nausea" statement, while on the right end there is 10 "Nausea is very severe" statement.

    The patient will be asked to mark the point on the line that will accurately reflect his or her nausea state. In addition, the patient will be asked to write down the number of nausea and vomiting numerically.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Koc University Hospital

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 5, 2022
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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